OnychomycosisPhase 3NCT01208168
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
A Phase 3 study testing NAB001 in people with Onychomycosis, run by Promius Pharma, LLC at 24 sites in 2 countries.
Trial summary
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- NAB001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Sep 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate fungal infection of the toenail as assessed by study doctor
- koh positive \& dermatophyte culture positive at Visit 1
- good general health as assessed by the study doctor
Who cannot join
- severe fungal toenail infection
- prior use of antifungal drugs (wash-out allowed, duration varies on class)
- significant confounding conditions as assessed by study doctor
- pregnancy/lactation
- must forego nail salon procedures during study for at least ~60 weeks
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 sites
Northwest Clinical Trials
Boise, Idaho, 83704
Radiant Research
Cincinnati, Ohio, 45249
Ashton Podiatry Associates, PA
Dallas, Texas, 75243
Gerard Furst, DPM, PLLC
East Setauket, New York, 11733
T. Joseph Raoof, MD, Inc.
Encino, California, 91436
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Carolina Dermatology of Greenville, PA
Greenville, South Carolina, 29681
Dermatology Consulting Services
High Point, North Carolina, 27262
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Longmont Medical Research Network
Longmont, Colorado, 80501
Internaional Dermatology Research, Inc.
Miami, Florida, 33144
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
MedaPhase, Inc.
Newnan, Georgia, 30263
Temple University - School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arkansas, 85032
Oregon Dermatology & Research Network
Portland, Oregon, 97210
Wake Research Associates
Raleigh, North Carolina, 27612
Mazur Foot and Ankle
Salisbury, North Carolina, 28144
Progressive Clinical Research
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Dominican Republic2 sites
Instituto Dermatologica
Santo Domingo
Instituto Dermatologico
Santo Domingo
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
- Conditions
- Onychomycosis
- Being tested
- NAB001, Vehicle alone
- Keywords
- toenail fungus, onychomycosis, nail infection
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAB001Drug
nail lacquer, once daily, 52 weeks
Vehicle aloneDrug
nail lacquer, once daily, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Experimental | Not described Receives: Drug: NAB001 |
| Vehicle alone | Placebo comparator | Not described Receives: Drug: Vehicle alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
Measured: Week 56 after 52 weeks of treatment
Secondary outcomes (1)
Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear).
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kent Allenby, MD, Study director, Promius PharmaJoanne Fraser, PhD, Study director, Promius Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208168
- Sponsor's protocol ID
- 0904
- Status last verified
- Jul 2013
- First submitted
- 20 Sep 2010
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks
- ClinicalTrials.gov ID
- NCT01208168
- Acronym / sponsor ID
- 0904
- Conditions
- Onychomycosis
- Keywords
- toenail fungus, onychomycosis, nail infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Experimental | Drug: NAB001 |
| Vehicle alone | Placebo comparator | Drug: Vehicle alone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild to moderate fungal infection of the toenail as assessed by study doctor
- koh positive \& dermatophyte culture positive at Visit 1
- good general health as assessed by the study doctor
Key exclusion criteria (5 listed)
- severe fungal toenail infection
- prior use of antifungal drugs (wash-out allowed, duration varies on class)
- significant confounding conditions as assessed by study doctor
- pregnancy/lactation
- must forego nail salon procedures during study for at least ~60 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAB001nail lacquer, once daily, 52 weeks | Drug | Active drug |
| Vehicle alonenail lacquer, once daily, 52 weeks | Drug | Vehicle alone |
Primary outcome
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
Time frame: Week 56 after 52 weeks of treatment
1 secondary outcome
Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear).
Time frame: Week 56
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Allenby, MD study director
Promius Pharma
Joanne Fraser, PhD study director
Promius Pharma
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAB001 in people with Onychomycosis, run by Promius Pharma, LLC at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. (time frame: Week 56 after 52 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.